The ISO 14071 standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality management system standards such as ISO 13485.
Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and management, and also specifies a procedure for review and monitoring during production and post-production. In 2012, a European harmonized version of this standard was adopted by the European Committee for Standardization (CEN) as EN ISO 14971:2012. This version is harmonized with respect to the three European Directives associated with medical devices , and In-vitro Diagnostic Medical Device Directive , and Active Implantable Medical Device Directive.